Prevention of Nosocomial Bacteremia Among Zambian Neonates

Neonatal Sepsis Clinical Trial

Official title:

Prevention of Nosocomial Bacteremia and Mortality Among Neonates at a Tertiary Referral Center in Zambia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02386592
• Other study ID #: H-33473
• Status: Completed
• Phase: N/A
• First received: February 17, 2015
• Last updated: July 27, 2017
• Start date: September 1, 2015
• Est. completion date: July 2017

Study information

• Verified date: July 2017
• Source: Boston University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to estimate the burden of disease, identify risk factors associated with nosocomial bacteremia among neonates and assess the efficacy of low-cost measures targeted to known and suspected nosocomial BSI (bloodstream) risk factors, the investigators propose to study the impact of a novel package of infection control interventions on nosocomial bacteremia and mortality among neonates at a tertiary care center in sub-Saharan Africa.

Description:

The study is an18 month prospective quasi-experimental evaluation of nosocomial bacteremia and mortality among hospitalized neonates and will consist of a 6-month baseline period to capture the incidence and all-cause mortality of nosocomial BSIs, a 1-month implementation period of low-cost infection control strategies (including alcohol-based hand rub [AHR], 2% chlorhexidine gluconate [CHG], hospital staff education and text message-based reminders of infection control recommendation) and an 11-month intervention period.

All neonates admitted to the neonatal intensive care unit (NICU) of the University Teaching Hospital (UTH) in Lusaka, Zambia during the study period will be eligible for study enrollment. This study will determine the capacity of an innovative bundle of low cost, simple and locally available interventions that leverage new technologies and expand application of highly effective interventions in order to reduce the incidence of nosocomial bacteremia among NICU patients in a developing country setting.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9410
• Est. completion date: July 2017
• Est. primary completion date: April 15, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 28 Days

Eligibility

Inclusion Criteria:

• Neonates admitted to the study site NICU during the study period (including both "inborn" and "outborn" neonates)

Exclusion Criteria:

• Neonates without documented birth date

• Parent or guardian unavailable or unwilling to provide consent

Related Conditions & MeSH terms

• Bacteremia
• Neonatal Mortality
• Neonatal Sepsis

Intervention

Drug:
• Chlorhexidine gluconate (CHG)
All enrolled neonates admitted to the NICU during the implementation and intervention periods will undergo CHG bathing (sparing head and face) at the time of admission at and thereafter once weekly.

Behavioral:
• Hand hygiene (HH)
Alcohol hand rub will be produced in the hospital pharmacy and will be readily available in the NICU (via wall-mounted dispensers) throughout the intervention period. Hand hygiene among NICU physicians and nurses will actively be promoted through the intervention period.
• Infection control training
All NICU healthcare workers will receive infection prevention training which will involve structure training on HH, universal precautions, neonatal skin antisepsis and peripheral IV placement and line care.

Other:
• Infection control reminders via SMS text
Infection control practice reminders will be sent to NICU healthcare workers on a daily basis via SMS messages.

Locations

Country	Name	City	State
Zambia	University Teaching Hospital	Lusaka

Sponsors (4)

Lead Sponsor	Collaborator
Boston University	Children's Hospital of Philadelphia, University Teaching Hospital, Lusaka, Zambia, Zambia Center for Applied Health Research and Development

Country where clinical trial is conducted

Zambia, 

References & Publications (3)

Aiken AM, Mturi N, Njuguna P, Mohammed S, Berkley JA, Mwangi I, Mwarumba S, Kitsao BS, Lowe BS, Morpeth SC, Hall AJ, Khandawalla I, Scott JAG; Kilifi Bacteraemia Surveillance Group. Risk and causes of paediatric hospital-acquired bacteraemia in Kilifi District Hospital, Kenya: a prospective cohort study. Lancet. 2011 Dec 10;378(9808):2021-2027. doi: 10.1016/S0140-6736(11)61622-X. Epub 2011 Nov 29. — View Citation

Gill CJ, Mantaring JB, Macleod WB, Mendoza M, Mendoza S, Huskins WC, Goldmann DA, Hamer DH. Impact of enhanced infection control at 2 neonatal intensive care units in the Philippines. Clin Infect Dis. 2009 Jan 1;48(1):13-21. doi: 10.1086/594120. — View Citation

Milstone AM, Elward A, Song X, Zerr DM, Orscheln R, Speck K, Obeng D, Reich NG, Coffin SE, Perl TM; Pediatric SCRUB Trial Study Group. Daily chlorhexidine bathing to reduce bacteraemia in critically ill children: a multicentre, cluster-randomised, crossover trial. Lancet. 2013 Mar 30;381(9872):1099-106. doi: 10.1016/S0140-6736(12)61687-0. Epub 2013 Jan 28. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	All-cause neonatal mortality in hospitalized neonates	in hospitalized neonates at University Teaching Hospital (UTH), a large tertiary referral center, in Zambia before and after the introduction of low-cost infection-control interventions.	18 months
Secondary	Incidence of nosocomial bacteremia in hospitalized neonates	Incidence of nosocomial bacteremia in hospitalized neonates at UTH before and after the introduction of low-cost infection-control interventions.	18 months
Secondary	Attributable risk of maternal, neonatal, hospital factors and nosocomial bacteremia among hospitalized neonates	Measure the attributable risk of maternal, neonatal and hospital factors as well as invasive procedures on nosocomial bacteremia among neonates hospitalizedat UTH	18 months
Secondary	Prevalence of nosocomial bacteremia caused by MDR-GNR infections among hospitalized neonates	Prevalence of nosocomial bacteremia caused by MDR-GNR infections among neonates at UTH.	18 months